The Oncology Center of Excellence (OCE) advances regulatory science and policy to improve cancer prevention, diagnosis and treatment. Through a portfolio of specialized programs and projects, OCE coordinates cross-center activities, fosters collaboration with external stakeholders, and supports the development and evaluation of innovative therapies for people with cancer.
The Cancer in Older Adults Program seeks to improve outcomes for older adults with cancer through targeted research and stakeholder engagement.
The Cardio-Oncology Program promotes cardiovascular health in cancer patients and survivors by integrating cardiovascular considerations into oncology care and drug development.
The Immuno-oncology Therapeutics Program coordinates FDA expertise to support the development of therapies that harness the immune system to advance cancer treatment paradigms.
The Scientific Collaborative supports FDA oncology staff engaged in applied regulatory science research and fosters collaborations with internal and external experts.
The Oncology Artificial Intelligence Program advances understanding and application of artificial intelligence in oncology drug development.
The Oncology Cell and Gene Therapy Program focuses on clinical evaluation and expedited development of transformative cell- and gene-based cancer therapies with curative potential.
The Oncology Labeling Program provides a cross-center approach to develop clinically meaningful, data-driven, and scientifically accurate drug information for healthcare practitioners and patients.
The Oncology Real World Evidence Program promotes modernization of evidence development through scientific collaboration and policy work to support appropriate use of real-world data for regulatory purposes.
Oncology Regulatory Affairs enhances cross-center coordination of oncology product clinical review and regulatory strategy.
The Patient-Focused Drug Development Program fosters collaboration between FDA centers and external stakeholders to incorporate patient outcomes research into oncology regulatory decision-making.
The Pediatric Oncology Program promotes the development of safe and effective drugs and biologics to treat cancer in children.
The Precision Oncology Program coordinates efforts across centers to catalyze regulatory science research and apply new methodologies that enable precision medicine, including targeted drugs, diagnostics, and biologics.
The Rare Cancers Program supports the development of safe and effective therapies for patients with rare cancers.
Project 5 in 5 crowdsources five clinically relevant questions to inform five pragmatic trials.
Project Asha is a collaboration to expand cancer clinical trial access in India.
Project Catalyst provides guidance and educational resources to support anticancer therapy development, working primarily with small companies and academic incubators to accelerate novel treatments.
Project Confirm promotes transparency of outcomes related to accelerated approval for oncology indications.
Project Endpoint advances the use and evaluation of clinical endpoints in oncology drug development.
Project Facilitate serves as a single point of contact to help oncology healthcare providers and regulatory professionals submit individual patient Expanded Access requests through the FDA.
Project FrontRunner encourages developers to consider the most appropriate line-of-treatment setting, including earlier clinical settings, when advancing cancer therapies.
Project Livin’ Label is an educational initiative to increase understanding of oncology product labels and awareness of recent FDA approvals.
Project Optimus aims to reform dose optimization and selection practices in oncology drug development.
Project Orbis provides a framework for concurrent submission and review of oncology products among international regulatory partners.
Project Patient Voice is an online platform presenting patient-reported symptom data collected from cancer clinical trials for use by patients, caregivers, and healthcare providers.
Project Point/Counterpoint produces a combined Oncologic Drugs Advisory Committee briefing document that presents both the sponsor’s and the FDA’s positions in a single resource.
Project Pragmatica seeks to introduce efficiencies and enhance patient centricity by integrating pragmatic elements of clinical trial design with real-world clinical practice.
Project Renewal is a public health initiative to update prescribing information for select older oncology drugs so labeling remains clinically meaningful and scientifically current.
Project Significant (Statistics in Cancer Trials) promotes collaboration among stakeholders to improve the design and analysis of cancer clinical trials.
Project Socrates offers educational opportunities for hematology/oncology fellows, basic and translational scientists, junior faculty, and others interested in regulatory science and drug development.
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